Intensive Nutrition in Acute Respiratory Distress Syndrome (ARDS): A Clinical Trial (INTACT)

NCT ID: NCT01921101

Last Updated: 2014-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators propose a prospective randomized clinical trail to evaluate the impact of intensive medical nutrition therapy (IMNT) in patients with acute respiratory distress syndrome (ARDS) or acute lung injury (ALI) on short and long-term outcomes. Participant's (N = 200) will be randomized to receive either standard care (SC e.g. ad lib feeding of standard food) or IMNT provided early as enteral nutrition (EN) and continued as intensive diet therapy tailored to maximize oral intake until hospital discharge. Primary outcomes evaluated include infections while hospitalized, immune parameters (CD4 and CD8 cells, serum IL-10 and leptin levels, numbers of T regulatory cells and markers for T cell anergy), days on mechanical ventilation, in the ICU and hospital , and changes in fat free mass(measured by dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip strength), fatigue (measured as distanced traveled in 6-minute walk) and pulmonary function.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was terminated early due to greater deaths occurring in the intervention group vs the control group. There were a total of 22 deaths, 16 in the intervention and 6 in the control.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lung Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intensive medical nutrition

participants will receive intensive medical nutrition from hospital admission to discharge

Group Type OTHER

intensive medical nutrition

Intervention Type BEHAVIORAL

provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge

control

participants will not receive intensive nutritional support from hospital admission to discharge

Group Type OTHER

control

Intervention Type OTHER

participants will receive standard care for nutrition received from hospital admission to discharge

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intensive medical nutrition

provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge

Intervention Type BEHAVIORAL

control

participants will receive standard care for nutrition received from hospital admission to discharge

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carol Braunschweig

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

carol l braunschweig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Sheean PM, Peterson SJ, Chen Y, Liu D, Lateef O, Braunschweig CA. Utilizing multiple methods to classify malnutrition among elderly patients admitted to the medical and surgical intensive care units (ICU). Clin Nutr. 2013 Oct;32(5):752-7. doi: 10.1016/j.clnu.2012.12.012. Epub 2013 Jan 5.

Reference Type BACKGROUND
PMID: 23340043 (View on PubMed)

Sheean PM, Peterson SJ, Zhao W, Gurka DP, Braunschweig CA. Intensive medical nutrition therapy: methods to improve nutrition provision in the critical care setting. J Acad Nutr Diet. 2012 Jul;112(7):1073-9. doi: 10.1016/j.jand.2012.02.007. Epub 2012 May 12.

Reference Type BACKGROUND
PMID: 22579721 (View on PubMed)

Peterson SJ, Sheean PM, Braunschweig CL. Orally fed patients are at high risk of calorie and protein deficit in the ICU. Curr Opin Clin Nutr Metab Care. 2011 Mar;14(2):182-5. doi: 10.1097/MCO.0b013e3283428e65.

Reference Type BACKGROUND
PMID: 21178611 (View on PubMed)

Braunschweig CA, Sheean PM, Peterson SJ. Examining the role of nutrition support and outcomes for hospitalized patients: putting nutrition back in the study design. J Am Diet Assoc. 2010 Nov;110(11):1646-9. doi: 10.1016/j.jada.2010.08.019.

Reference Type BACKGROUND
PMID: 21034876 (View on PubMed)

Sheean PM, Peterson SJ, Gurka DP, Braunschweig CA. Nutrition assessment: the reproducibility of subjective global assessment in patients requiring mechanical ventilation. Eur J Clin Nutr. 2010 Nov;64(11):1358-64. doi: 10.1038/ejcn.2010.154. Epub 2010 Aug 11.

Reference Type BACKGROUND
PMID: 20700137 (View on PubMed)

Peterson SJ, Tsai AA, Scala CM, Sowa DC, Sheean PM, Braunschweig CL. Adequacy of oral intake in critically ill patients 1 week after extubation. J Am Diet Assoc. 2010 Mar;110(3):427-33. doi: 10.1016/j.jada.2009.11.020.

Reference Type BACKGROUND
PMID: 20184993 (View on PubMed)

Braunschweig CA, Sheean PM, Peterson SJ, Gomez Perez S, Freels S, Lateef O, Gurka D, Fantuzzi G. Intensive nutrition in acute lung injury: a clinical trial (INTACT). JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):13-20. doi: 10.1177/0148607114528541. Epub 2014 Apr 9.

Reference Type RESULT
PMID: 24722769 (View on PubMed)

Braunschweig CL, Freels S, Sheean PM, Peterson SJ, Perez SG, McKeever L, Lateef O, Gurka D, Fantuzzi G. Role of timing and dose of energy received in patients with acute lung injury on mortality in the Intensive Nutrition in Acute Lung Injury Trial (INTACT): a post hoc analysis. Am J Clin Nutr. 2017 Feb;105(2):411-416. doi: 10.3945/ajcn.116.140764. Epub 2016 Dec 14.

Reference Type DERIVED
PMID: 27974311 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

685

Identifier Type: -

Identifier Source: org_study_id

NCT01071330

Identifier Type: -

Identifier Source: nct_alias

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ICU Nutrition Study Bern
NCT00574431 COMPLETED PHASE4